ISO 10993-3:2026 introduces important updates to the biological evaluation of medical devices, with greater emphasis on risk-based evaluation, chemical characterization and toxicological assessment. Explore the key changes and implications for medical device manufacturers.
Published: 17 June 2026 The European Commission has published Commission Implementing Decision (EU) 2026/1231, introducing important updates to the list of harmonized standards supporting compliance with Regulation (EU) 2017/745 on Medical Devices (EU MDR). Harmonized standards play an important role in demonstrating conformity with the applicable requirements of the EU MDR. Manufacturers that apply the…
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